Recruiting

Observational Study

Sponsor:

Hospital Universitari Vall d'Hebron Research Institute

Code:

NCT04707729

Conditions

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ROX index algorithm

Study Details

Brief summary:

Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria.

The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.

Conditions

Acute Hypoxemic Respiratory Failure

Study ID

NCT04707729

Start date

Dec 9, 2020

Status verified date

Jul, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.

  • Criteria for initiation of NHF if they had a respiratory rate > 25 breaths/min and/or pulse oximetry (SpO2) < 92% while receiving standard oxygen administered through a facemask at 10 L/mn or more.
  • Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.

Exclusion Criteria:

  • Patients younger than 18 years old.
  • Patients with indication for immediate intubation.
  • Patients treated with NHF for more than 1h prior to randomization.
  • Patients with do-not-intubate order.
  • Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).
  • Patients with no pulmonary infiltrates on chest X-ray
  • Patient with post-extubation AHRF.
  • Awake ECMO.
  • Pregnancy.
  • Refusal to participate or participation in another interventional study with the same primary outcome.

Study Design

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Standard of care

Patients will be intubated according to both the standard of care

experimental: Standard of care + ROX algorithm

In the intervention arm, patients will be intubated according to both the standard of care and the ROX index, whichever are met first. If the patient has a ROX index below different thresholds after different time-point within the first 12 hours since randomization, the NHF support will be increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. Then, the ROX index will be recalculated in 30 minutes. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done, the ROX index will be recalculated after 30 minutes of full NHF support. Then: 1) if the ΔROX is <0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 30 minutes; and 3) if the ΔROX is >0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.

Interventions

ROX index algorithm

The thresholds of the ROX index for intubation are the following:

  • After 2 hours of HFNC: ROX <2.85.
  • After 4 and 6 hours of HFNC: ROX <3.47
  • After 8, 10 and 12 hours of HFNC: ROX <3.85 If the ROX index is between the abovementioned thresholds and 4.88, the NHF support will be also increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done and the ROX index will be recalculated after 30 minutes of full NHF support. The ROX index will be recalculated in 30 minutes: 1) if the ΔROX is <0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 20 minutes; and 3) if the ΔROX is >0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration.

Primary outcome measure

  • Early intubation [ Time Frame: 12 hours since HFNC onset ]

Central Contacts and Locations

Central contacts

Oriol Roca, MD PhD

+34932746209oroca@tauli.cat

Locations

Rush University Chicago Hospital

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jie Li, MD PhD

jie_li@rush.edu

Principal Investigator:

Jie Li, MD PhD

More Information

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Last update posted

Aug 15, 2024

Last verified

Jul, 2024

Keywords

  • High flow nasal cannula
  • Nasal high flow
  • High flow oxygen therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute on 2024-08-15.